Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

December 2, 2013 updated by: Paul Ritvo, Ph.D., Cancer Care Ontario

Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial

Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual.

A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their preferred tests, after undergoing the "Patient Navigator" intervention and that proportion will be significantly greater than the group who opt for FOBT in the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Outcome Measure:

Number of patients who receive a letter and patient navigation services and get screened compared to the control group.

Secondary Outcome Measures:

Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and screening preference.

Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary care practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be screened for eligibility and those who are eligible and agree to participate in the study will be randomized to either of the two study arms: intervention group or control group.

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Sault Ste. Marie, Ontario, Canada
        • Group Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Average risk men and women aged 50 - 74
  • Unscreened - Defined as no prior CRC screening
  • Under-screened - Defined as no FOBT screening within the last two years
  • No colonoscopy or barium enema screening within the last five years
  • Willing to provide consent to participate in the study.

Exclusion Criteria:

  • FOBT within the last two years
  • colonoscopy within five years
  • barium enema within five years
  • flexible sigmoidoscopy within five years
  • Bowel cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Navigator intervention
Behavioral: Health counselling by nurse navigator
Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral
Other Names:
  • Nurse navigator assistance
Active Comparator: Usual Care Control
Usual care
Behavioral: Usual primary care counselling
Usual care health counselling on colorectal cancer and screening options
Other Names:
  • Usual primary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks
Time Frame: 48 weeks after baseline assessment
Completion of verified CRC screening events in experimental vs. control patients
48 weeks after baseline assessment

Secondary Outcome Measures

Outcome Measure
Time Frame
Screening preferences; predictors of CRC screening and screening preference.
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Care Ontario

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Paul Ritvo, PHD, Cancer Care Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 10, 2012

Study Record Updates

Last Update Posted (Estimate)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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